FLUORIDE TREATMENT- sodium fluoride solution
3M ESPE Dental Products
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use 3MTM ESPETM Fluoride Treatment 2% Sodium Fluoride Aqueous Solution safely and effectively. See full prescribing information for Fluoride Treatment 2% Sodium Fluoride Aqueous Solution.
Initial U.S. Approval INDICATIONS AND USAGEFluoride Treatment 2% Sodium Fluoride Aqueous Solution is indicated for topical application by a dental professional to aid in the prevention of dental caries. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSColorless solution containing 2% sodium fluoride for delivery in a disposable tray (3) CONTRAINDICATIONSAvoid use in patients with known hypersensitivity to fluoride. (4) WARNINGS AND PRECAUTIONSADVERSE REACTIONSAllergic reactions and other idiosyncrasies have been rarely reported. (6) To report SUSPECTED ADVERSE REACTIONS, contact 3M ESPE Dental Products Division at 1-800-634-2249 or www.3MESPE.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: 5/2013 |
FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS6 ADVERSE REACTIONS8 USE IN SPECIFIC POPULATIONS10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY15 REFERENCES16 HOW SUPPLIED/STORAGE AND HANDLING
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Fluoride Treatment 2% Sodium Fluoride Aqueous Solution is indicated for topical application by a dental professional to aid in the prevention of dental caries.
Colorless solution containing 2% sodium fluoride for delivery in a disposable tray
No studies of Fluoride Treatment have been conducted to determine whether pediatric, geriatric, pregnant, or nursing mothers respond differently from other subjects.
Ingestion of high levels of fluoride may result in abdominal pain, weakness, tremor, spasm, or convulsions. These symptoms may occur at overdosage of 5 mg/kg of body weight. Fluoride doses of 16 mg/kg have been fatal.2
One upper and one lower medium size tray filled with Fluoride Treatment contain a total of 42.9 mg of fluoride. If an average 6 year old child who weighs 22.6 kg (approximately 50 pounds) would swallow all the Fluoride Treatment contained in both upper and lower medium size trays, he or she would receive a fluoride dose equivalent to 1.9 mg/kg. This dose is 2.6 times less than the level that can begin to cause adverse effects.
Fluoride Treatment is a professionally-applied fluoride solution for delivery in a disposable tray for the prevention of dental caries. Each gram of solution contains fluoride (9 mg), xylitol, and tri-calcium phosphate in a neutral pH base.
Fluoride delivered from Fluoride Treatment inhibits caries formation by reducing enamel solubility and enhancing remineralization.
Fluoride Treatment is supplied as a colorless solution for delivery in a disposable tray. Fluoride Treatment is available in Bubble Gum Flavor (NDC 48878-3160-2).
Storage
This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date.
Manufactured by:
3M ESPE Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 U.S.A.
Revision date: April 2013
Rx Only
3M and ESPE are trademarks of 3M or 3M Deutschland GmbH.
Principal Display Panel – Box Label
3M ESPE NDC 48878-3160-2
Fluoride Treatment Rx Only
2% Sodium Fluoride Aqueous Solution Bubble Gum
Active Ingredient: Sodium fluoride (9049 ppm F-) 2.0% w/w (0.93 % w/v fluoride ion)
Indication and Use: Indicated for single use, topical application by a dental professional to aid in the prevention of dental caries.
Warnings: DO NOT SWALLOW. Keep out of reach of children under 6 years of age. Read full prescribing information before using this product. Do not freeze or expose to extreme heat.
Inactive Ingredients: flavor; tricalcium phosphate, water, xylitol, other ingredients in a neutral pH base
Contents: NET WT 0.17 oz. (4.75 grams)
Questions? 1-800-634-2249
www.3MESPE.com
3M and ESPE are trademarks
of 3M or 3M Deutschland GmbH.
Used under license in Canada.
© 3M 2013. All rights reserved
Made in U.S.A. for
3M ESPE, Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 USA
REF 12195
LOT EXD-819
FLUORIDE TREATMENT
sodium fluoride solution |
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Labeler - 3M ESPE Dental Products (801390852) |